Quality Assurance Technician

PE Global; Sligo; On-site; EUR 36,000 - 48,000; Full time

Job summary

PE Global are currently recruiting for a Quality Technician for our Medical Device client site in Sligo on a 12-month initial contract. This role sits within the Quality Assurance department and focuses on GMP-compliant testing, documentation, and process improvements.

Responsibilities include testing at incoming, in-process and final stages, maintaining quality system records, auditing, and supporting Change Management with metrics for management reviews.

Qualifications

• 1 year plus experience in day-to-day operation of the quality system in a regulated GMP environment.
• High level of attention to detail and ability to adapt to new processes regularly.
• Familiarity with cGMP and ISO/FDA regulations within a manufacturing setting.

Responsibilities

• Work as a member of the Quality Team to ensure quality goals are achieved.
• Ensure actions comply with current good manufacturing practices.
• Operate within QC/IQA and Metrology areas as required.
• Complete incoming product testing per approved specifications and procedures.
• Complete in-process and final release product testing per approved specifications.
• Keep management informed of quality events or potential events.
• Maintain and ensure quality system documentation is thorough and compliant.
• Audit the quality system with other personnel as required.
• Support Change Management including document reviews and updates.
• Generate and providing metrics for management review and monthly reports.
• Ensure training requirements are maintained.
• Contribute to continuous improvement programs for quality, safety, and production systems.
• Generate batch records to support manufacturing processes.
• Complete disposition decisions for incoming material.

Skills

Quality assurance

GMP

cGMP

Attention to detail

Education

Third level qualification in an appropriate discipline

Job description

PE Global are currently recruiting for a Quality Technician for our Medical Device client site in Sligo on a 12-month initial contract:

QUALITY TECHNICIAN MEDICAL DEVICES

Job Dept: Quality Assurance

Responsibilities

• To work as a member of the Quality Team to ensure that Quality goals and objectives are achieved.
• Ensure that all actions comply with current good manufacturing practices.
• Operate within the QC/ IQA and Metrology Areas, as required.
• Complete incoming product testing per the relevant approved specifications and procedures.
• Complete in-process and final release product testing per the relevant approved specifications and procedures.
• Ensure Management is kept informed of all Quality Events or potential Quality Events Related to the product or process.
• Ensure all Quality System documentation is thorough, complete, and compliant.
• Audit the quality system with other personnel where required.
• Support Change Management Process including Product and Quality System document review and updates.
• Generate and Providing metrics for inclusion in the management review, monthly reports and overall Quality Performance
• Ensure compliance with training requirements is maintained.
• Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site.
• Generate batch records for as required in support of manufacturing process orders.
• Complete disposition decisions for incoming material
• A third level qualification in an appropriate discipline is desirable.
• 2+ years’ Experience within a regulated GMP environment is desirable.

Experience Required

• 1 year plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment is desirable.
• The position requires a high level of attention to detail and mental concentration, to ensure total compliance with operating procedures and Regulations at all times.
• The position requires the ability to adapt to new processes on a regular basis.
• The position requires total commitment to quality and safety at all times.
• Has a personal responsibility to commit to the Vision, to engage and align with the Strategic Imperatives, and to consistently execute in accordance with the Operational Pillars and Ways of Work
• Requires good knowledge of Company Policies and Procedures and involves. working towards general results to achieve organizational needs.
• Demonstrates an ethos of Right First Time at all times.
• Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and ISO/FDA regulations and company policies, procedures, and guidelines.
• Shows a high level of attention to detail and tenacity to ensure any issues noted are elevated to the Operations Quality Team Leader.
• Complies with cGMP at all times.
• Considerable and continual care and attention to detail is needed to detect and avoid errors.